Glaukos (GKOS) on Wednesday announced positive topline results from its phase 3 confirmatory trial for Epioxa, a corneal cross-linking treatment for keratoconus, a rare corneal disorder.
The trial achieved its primary efficacy endpoint, showing a clinically significant and statistically meaningful improvement in maximum corneal curvature, or Kmax at 12 months.
Key findings reveal a Kmax treatment effect of -1.0 diopter, with 91.5% of treated patients completing the 12-month trial with no reported serious treatment-related adverse events, and no evidence of systemic effects or changes in corneal endothelial cell counts, the company said.
Results from this second phase 3 confirmatory trial, along with the first phase 3 trial, are expected to support Glaukos' planned new drug application submission by the end of 2024.
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